Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

A Multi-Center Phase III Study to Investigate the Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00139841
• Other study ID #: SDX-105-03
• Status: Completed
• Phase: Phase 3
• First received: August 18, 2005
• Last updated: May 8, 2014
• Start date: October 2005
• Est. completion date: October 2009

Study information

• Verified date: May 2014
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

SUMMARY: This is a multi-center open label study to evaluate the safety and effectiveness of Treanda™ (also known as bendamustine HCl or SDX-105) in patients who have indolent Non-Hodgkin's lymphoma and have relapsed within a defined timeframe after taking rituximab (Rituxan®). Treanda will be given via 60-minute intravenous infusion on days 1 and 2 of every 21-day treatment cycle. Patients will be treated for 6 cycles unless they develop progressive disease or unacceptable toxicity. Those who continue to receive clinical benefit at end of 6 cycles may receive an additional 2 cycles. Following the end of treatment, patients will be followed for up to 2 years until disease progression or start of another anti-cancer therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: October 2009
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

ELIGIBILITY:

Key Inclusion Criteria

• Documented B-cell Non-Hodgkin's Lymphoma

• Small lymphocytic lymphoma (ALC < 5,000 cells/mm3)

• Marginal zone B-cell lymphoma (nodal, extranodal, or splenic types)

• Lymphoplasmacytic lymphoma

• Follicular center lymphoma, follicular

Disease documented to be refractory to a full-course of the most recent rituximab therapy (single agent or combination)

• At least 1 prior chemotherapy regimen and maximum of 3 prior chemotherapy regimens

• Bidimensionally measurable disease (by CT scan) with at least one lesion measuring = 2.0 cm in a single dimension

Key Exclusion Criteria

• Patients who receive rituximab only as part of treatment with ibritumomab tiuxetan (Zevalin®) will not be eligible

• History of prior high dose chemotherapy with allogeneic stem cell support (history of autologous stem cell support is permissible)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• Bendamustine HCl
Dose of 120 mg/m2 on Day 1 and Day 2 of each treatment cycle (every 21 days). Patients who are continuing to experience clinical benefit at Cycle 6, as assessed by the investigator, may receive up to 2 additional cycles, to a maximum of 8 cycles.

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Queen Elizabeth Health Sciences Centre	Halifax	Nova Scotia
Canada	Hopital du Sacre Couer de Montreal	Montreal	Quebec
Canada	Hopital Notre-Dame du CHUM	Montreal	Quebec
Canada	Ottawa Hospital - General Campus	Ottawa	Ontario
Canada	Saskatchewan Cancer Center Agency	Saskatoon	Saskatchewan
Canada	British Columbia Cancer Agency	Vancouver	British Columbia
Puerto Rico	Hospital Espanol Auxilio Mutuo, Auxilio Mutuo Cancer Center	San Juan
United States	University of New Mexico Cancer Research and Treatment Center	Albuquerque	New Mexico
United States	University of Michigan Cancer Center	Ann Arbor	Michigan
United States	Arlington Cancer Center	Arlington	Texas
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Alta Bates Comprehensive Cancer Center	Berkeley	California
United States	Tower Hematology and Oncology Medical Group	Beverly Hills	California
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	University of Virginia Cancer Center	Charlottesville	Virginia
United States	Rush University Medical Center	Chicago	Illinois
United States	The Cleveland Clinic Foundation Taussig Cancer Center	Cleveland	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	Duke University School of Medicine	Durham	North Carolina
United States	Indiana Oncology Hematology Consultants, A Division of AHN	Indianapolis	Indiana
United States	Moores UCSD Cancer Center	La Jolla	California
United States	Nevada Cancer Institute	Las Vegas	Nevada
United States	Markey Cancer Center, University of Kentucky Medical Center	Lexington	Kentucky
United States	USC/Norris Cancer Hospital	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	The West Clinic/ACORN	Memphis	Tennessee
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Weill Cornell Cancer Care Center	New York	New York
United States	Comprehensive Cancer Center - Desert Regional Medical Center	Palm Springs	California
United States	Interlakes Foundation, Inc.	Rochester	New York
United States	University of Rochester Medical Center, James P. Wilmot Cancer Center	Rochester	New York
United States	LSU Health Sciences Center, Feist Weiller Cancer Center	Shreveport	Louisiana
United States	Washington University School of Medicine in St. Louis	St. Louis	Missouri
United States	Stanford University Division of Oncology	Stanford	California
United States	Arizona Cancer Center	Tucson	Arizona
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the overall response rate (ORR = CR + CRu + PR) and duration of response (DR) to a regimen of bendamustine in patients who are refractory to rituximab therapy.		6 months	No
Secondary	• assess the safety profile of Treanda in this patient population. • assess the duration of progression-free survival (PFS). • estimate the basic pharmacokinetic parameters • assess the effects of plasma concentrations		6 months	Yes